What do a cup of cappuccino and sterile water for injection have in common? At first glance, there is no apparent correlation, except when you become “data curious” and take the macro view of the current convergence of economics, compliance, and maturation of risk management. Sometimes utilizing existing data is the best way to understand where there are lead data indicators. Understanding how to use these indicators can help organizations advance their data governance maturity, going from “reactive” to “proactive.” This simple example exemplifies the fact that we all had visibility to the “race to the bottom,” but did we act? A deeper dive into this paradigm is an uncomfortable but necessary exercise.
Lean sigma principles (long touted as the key to driving quality into product) has a mantra of “value in the eyes of the customer.” The difference between the typical consumer and the pharmaceutical consumer (patient) is that, in pharma, the “payer” and the “consumer” are either fundamentally different entities or the payer may have a disproportionate influence over the “consumer.” This is a basic starting point to understanding the report from the multiagency federal task force report that states the “root cause for many drug shortages is the absence of incentives for manufacturers to strive for… mature quality management systems” (CDER Quality Management Maturity | FDA). Lachman is a proud and committed partner helping to address this global issue. One of our significant partnerships is our involvement as a founding member of the DukeMargolis Drug Supply Chain Resilience and Advanced Manufacturing Consortium (DukeMargolis Launches Drug Supply Chain Resilience and Advanced Manufacturing Consortium). As with any journey, an assessment of the “current state” is needed in order to map out the path forward. This journey is no different as the “maturity of a site” is vastly different from the “maturity of a supply chain.”
Now, back to that cappuccino… and our awareness of this commodity. A 16ounce cappuccino (estimated cost of $5.25) at a popular coffee shop is about the same catalogue price (estimated $5.78) as a 1,000mL IV bag of sterile water for injection. How much do we know about the supply chain of coffee? Typically, we know quite a bit. In fact, many consumers value the fact that the coffee they drink may be fair trade or have a specific country of origin. We also typically understand how disruptions in the coffee supply chain will impact the nearly two billion cups that are consumed each day globally. All of this can influence our spending habits and quest for quality. The paradox is that our knowledge of the seemingly basic needs of patients and the risks in the supply chains that we rely on are not as robust as this.
Looking at these examples simplifies the key leadership messages of:
- Do you know your supply chain risks?
- Do you know the active mitigation plans pursued by federal agencies and have you incorporated them into your own regulatory intelligence response plans?
- Where are you on your data governance journey and are you incorporating the principles of data governance into your risk management program?
Lachman Consultants is a key leader in these aspects and is readily available to help companies invest not only in their own sites and operations but increase awareness of their holistic supply chain and help develop data governance plans for sustained operations. Please reach out to LCS@LachmanConsultants.com for an assessment.